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The MIRACL Study: A Randomized Controlled Trial

Gregory G. Schwartz, MD,PhD; Anders G. Olsson, MD,PhD; Michael D. Ezekowitz, MD,PhD; Peter Ganz, MD; Michael F. Oliver, MD; David Waters, MD; Andreas Zeiher, MD; Bernard R. Chaitman, MD; Sally Leslie, PhD; Theresa Stern, PhD; for the Myocardial Ischemia Reduction with Aggressive Cholesterol Lowering (MIRACL) Study Investigators

JAMA. 2001;285:1711-1718.

Context  Patients experience the highest rate of death and recurrent ischemic events during the early period after an acute coronary syndrome, but it is not known whether early initiation of treatment with a statin can reduce the occurrence of these early events.

Objective  To determine whether treatment with atorvastatin, 80 mg/d, initiated 24 to 96 hours after an acute coronary syndrome, reduces death and nonfatal ischemic events.

Design and Setting  A randomized, double-blind trial conducted from May 1997 to September 1999, with follow-up through 16 weeks at 122 clinical centers in Europe, North America, South Africa, and Australasia.

Patients  A total of 3086 adults aged 18 years or older with unstable angina or non–Q-wave acute myocardial infarction.

Interventions  Patients were stratified by center and randomly assigned to receive treatment with atorvastatin (80 mg/d) or matching placebo between 24 and 96 hours after hospital admission.

Main Outcome Measures  Primary end point event defined as death, nonfatal acute myocardial infarction, cardiac arrest with resuscitation, or recurrent symptomatic myocardial ischemia with objective evidence and requiring emergency rehospitalization.

Results  A primary end point event occurred in 228 patients (14.8%) in the atorvastatin group and 269 patients (17.4%) in the placebo group (relative risk [RR], 0.84; 95% confidence interval [CI], 0.70-1.00; P = .048). There were no significant differences in risk of death, nonfatal myocardial infarction, or cardiac arrest between the atorvastatin group and the placebo group, although the atorvastatin group had a lower risk of symptomatic ischemia with objective evidence and requiring emergency rehospitalization (6.2% vs 8.4%; RR, 0.74; 95% CI, 0.57-0.95; P = .02). Likewise, there were no significant differences between the atorvastatin group and the placebo group in the incidence of secondary outcomes of coronary revascularization procedures, worsening heart failure, or worsening angina, although there were fewer strokes in the atorvastatin group than in the placebo group (12 vs 24 events; P = .045). In the atorvastatin group, mean low-density lipoprotein cholesterol level declined from 124 mg/dL (3.2 mmol/L) to 72 mg/dL (1.9 mmol/L). Abnormal liver transaminases (>3 times upper limit of normal) were more common in the atorvastatin group than in the placebo group (2.5% vs 0.6%; P<.001).

Conclusion  For patients with acute coronary syndrome, lipid-lowering therapy with atorvastatin, 80 mg/d, reduces recurrent ischemic events in the first 16 weeks, mostly recurrent symptomatic ischemia requiring rehospitalization.

Author Affiliations: Cardiology Section, Veterans Affairs Medical Center and University of Colorado Health Sciences Center, Denver (Dr Schwartz); Faculty of Health Sciences, University of Linköping, Linköping, Sweden (Dr Olsson); Hahnemann University, Philadelphia, Pa (Dr Ezekowitz); Cardiovascular Division, Brigham and Women's Hospital and Harvard Medical School, Boston, Mass (Dr Ganz); Cardiac Medicine, National Heart and Lung Institute, Imperial College, London, England (Dr Oliver); Division of Cardiology, San Francisco General Hospital and University of California, San Francisco (Dr Waters); Cardiology Department, Johann Wolfgang Goethe University, Frankfurt, Germany (Dr Zeiher); Division of Cardiology, St Louis University School of Medicine, St Louis, Mo (Dr Chaitman); Pfizer Pharmaceutical Research, New York, NY (Dr Leslie); and Pfizer Pharmaceutical Research, Ann Arbor, Mich (Dr Stern). Dr Oliver is now retired.

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